Phase II Study of Cisplatin, Epirubicin, and Continuous-Infusion 5-Fluorouracil for Advanced Biliary Tract Cancer

Morizane, Chigusa; Okada, Shuichi; Okusaka, Takuji; Ueno, Hideki; Saisho, Toshimitsu

doi:10.1159/000070310

Cited by 21 publications

(12 citation statements)

References 2 publications

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“…Six trials in this analysis were identified, treating 206 patients. Four of the six trials used 5-FU [32–35] and the other two used capecitabine [36] or uracil/tegafur [37]. The median RR was 19%.…”

Section: Resultsmentioning

confidence: 99%

Identification of Active Chemotherapy Regimens in Advanced Biliary Tract Carcinoma: A Review of Chemotherapy Trials in the past Two Decades

et al. 2015

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Summary Biliary tract carcinoma is a rare malignancy. We performed a comprehensive analysis of published prospective clinical trials in advanced biliary tract carcinoma in an attempt to identify active regimens in this setting. We searched PubMed and abstracts presented at the American Society of Clinical Oncology, Gastrointestinal Cancer Symposium, European Society of Medical Oncology and European Cancer Organization conferences for clinical trials in this disease. We found 83 trials. The effect of gemcitabine on overall survival benefit showed a strong trend (p = 0.014) and an improvement in progression-free survival (p = 0.003). Gemcitabine-based regimens containing 5-fluorouracil showed a trend toward an improved overall survival (p = 0.047) relative to platinum agents. Our findings support gemcitabine as the chemotherapy backbone for the treatment of patients with cholangiocarcinoma. Gemcitabine plus 5-fluorouracil combinations warrant further investigations.

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Section: Resultsmentioning

confidence: 99%

Identification of Active Chemotherapy Regimens in Advanced Biliary Tract Carcinoma: A Review of Chemotherapy Trials in the past Two Decades

et al. 2015

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“…A wide range of response rates and OS data was reported in different clinical trials using a regimen of epirubicin, cisplatin, and FU (ORR 10%-40%; median OS, 5-11 months). 25,[35][36][37] Combinations of gemcitabine plus either oxaliplatin or capecitabine 22,32 yielded an ORRs from 31% to 33% and a median PFS of 5.7 to 7 months. The PEFG regimen produced better ORR and PFS with respect to all of those combinations, suggesting the contribution of each single agent in improving antitumor activity.…”

Section: Discussionmentioning

confidence: 99%

“…[17][18][19][20] Different combination chemotherapy regimens containing gemcitabine, anthracyclines, platinum analogs, S1, fluoropyrimidines, and mitomycin C reportedly produced ORRs between 15% and 45%, a median survival of 6 to 11 months, and a 1-year survival rate that ranged from 20% to 40%. [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] The combined regimen of cisplatin, epirubicin, FU, and gemcitabine (PEFG) is an effective, upfront treatment for advanced pancreatic cancer. 38,39 Because this combination regimen contains the most active drugs commonly administered in the therapeutic approach of biliary tract cancer, we decided to assess its activity against BTA.…”

mentioning

confidence: 99%

The cisplatin, epirubicin, 5‐fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma

Cereda

Passoni

Reni

et al. 2010

Cancer

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BACKGROUND: Biliary tract adenocarcinoma (BTA) is an uncommon tumor with a poor prognosis and no standard, systemic chemotherapy. The combined cisplatin, epirubicin, 5-fluorouracil, and gemcitabine (PEFG) regimen is an effective, upfront treatment for advanced pancreatic cancer. In this study, the authors assessed the activity and safety of this combination regimen in patients with advanced BTA. METHODS: PEFG (cisplatin 40 mg/m 2 and epirubicin 40 mg/m 2 on Day 1; gemcitabine 600 mg/m 2 on Days 1 and 8; and 5-fluorouracil [FU] 200 mg/m 2 daily as a continuous infusion) was administered to chemotherapy-naive patients who had a cytologic or histologic diagnosis of locally advanced or metastatic BTA, aged 75 years, and a performance status (PS) >60 either until they had evidence progressive disease or for a maximum of 6 months. Tumor size was assessed every 2 months during treatment. RESULTS: Between May 1999 and December 2005, 37 patients (62% metastatic) who had a median age of 62 years and a median PS of 90 received the PEFG regimen at the authors' institution. Primary tumor sites were the intrahepatic bile duct in 10 patients (27%), the extrahepatic bile duct in 8 patients (22%), the gallbladder in 12 patients (32%), and the ampulla of Vater in 7 patients (19%). A partial response was observed in 16 patients (43%), and stable disease was observed in 12 patients (32%). The median overall survival (OS) was 12.1 months, and the 1-year OS rate was 52%. The median progression-free survival (PFS) was 7.9 months, and the 6-month PFS rate was 67%. The main grade 3/4 toxicity was neutropenia in 18% of cycles followed by thrombocytopenia in 9% of cycles, nausea/vomiting in 5% of cycles, and febrile neutropenia, fatigue, anemia, and stomatitis in 2% of cycles. CONCLUSIONS: The current results demonstrated that PEFG was an active regimen with a manageable toxicity profile for patients with advanced BTA.

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“…Continuous infusion of 5-FU with cisplatin and epirubicin (ECF regimen) has been reported as an active chemotherapy in the management of upper gastrointestinal tumors [8]. With regard to biliary tract cancer, ECF chemotherapy has demonstrated encouraging response rates [9,10]. Several small-sized trials studied modified ECF regimens for gallbladder cancer, using epirubicin, cisplatin, 5-FU modulated by leucovorin or oral drugs such as capecitabine and Uracil plus tegafur (UFT) have been reported to have objective response rates ranging from 22.5 * 40% [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of two modified ECF regimens in the treatment of advanced gallbladder cancer

et al. 2010

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Gallbladder cancer is a rare disease and it is associated with a poor clinical outcome and survival. A standard therapy for it has not been established yet. The aim of this study is to evaluate efficacy and safety of two modified ECF regimens in advanced gallbladder cancer patients. Clinical data of 38 patients with advanced gallbladder cancer treated with modified ECF regimen were reviewed retrospectively. Of them, 21 patients received an epirubicin, cisplatin, and 5-FU/LV combination therapy. Seventeen patients received a chemotherapy of epirubicin, cisplatin, and capecitabine. Partial response was achieved in fourteen (36.84%) patients with a median duration of 5 months (range, 3-13 months), while stable disease was achieved in eight patients (21.05%). The median time to progression was 4.0 months (95% CI, 3.62-4.58 months). And the median overall survival was 9.8 months (95% CI, 7.26-12.34 months). Responders demonstrated better survival than non-responders (median survival time: 16 vs. 6.9 months, P = 0.008). The median survival time for epirubicin-, cisplatin- and capecitabine-treated patients was 9.2 versus 8.9 months for epirubicin-, cisplatin- and 5-FU/LV-treated patients. There was no statistical difference between both treatment groups in terms of survival time (P = 0.769). Regimen-related toxicity resulted in at least one treatment delay or dosage reduction in 63.2 and 34.2% patients, respectively. There were no chemotherapy-related deaths during the study. Modified ECF regimen with epirubicin, cisplatin and 5-FU/LV or substituting capecitabine for 5-FU/LV is still a potentially effective therapeutic chemotherapy for patients with advanced gallbladder cancer, and toxicity was manageable. There was no remarkable difference in efficacy between the two regimens.

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Phase II Study of Cisplatin, Epirubicin, and Continuous-Infusion 5-Fluorouracil for Advanced Biliary Tract Cancer

Cited by 21 publications

References 2 publications

Identification of Active Chemotherapy Regimens in Advanced Biliary Tract Carcinoma: A Review of Chemotherapy Trials in the past Two Decades

Identification of Active Chemotherapy Regimens in Advanced Biliary Tract Carcinoma: A Review of Chemotherapy Trials in the past Two Decades

The cisplatin, epirubicin, 5‐fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma

Evaluation of two modified ECF regimens in the treatment of advanced gallbladder cancer

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